Evaluation of the Effectiveness, Safety, and Cost of a Smart Hospital System for Patients With Chronic Obstructive Pulmonary Disease: Prospective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- Respiratory symptom questionnaire
研究概览
简要总结
This study aims to analyze the effectiveness/safety/cost of the Smart Homespital system that provides a service that allows patients with Chronic Obstructive Pulmonary Disease to easily access and use biosignals generated using biosignal collection medical equipment at home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with COPD who meet the following pulmonary function test results:
- •Pre FEV1 < 80% **or**
- •Pre FVC < 80% **or**
- •DLCO < 60%
排除标准
- •Patients who do not agree to participate in the study.
- •Patients who fail to use the medical device equipment.
- •Patients where tracking during the study period is expected to be impossible.
- •Patients who have difficulty communicating verbally.
- •Patients who are bedridden or unable to exercise at all due to severe cardiorespiratory dysfunction.
- •Patients receiving hospital-centered rehabilitation treatment during the study period.
研究组 & 干预措施
intervention group
The Smart Homespital system can be applied for the first 3 months (12 weeks), and then the primary and secondary variables will be evaluated at 3, 6, 9months.
干预措施: Immediate application of the Smart Homespital system (Behavioral)
attention-waitlist control group
The waiting list-control group will receive general medical services for the first 3 months and will receive the Smart Homespital system for 3-6 months. Primary and secondary variables will be evaluated between 3, 6, and 9 months.
干预措施: Delayed application of the Smart Homespital system after 3 months (Behavioral)
结局指标
主要结局
Respiratory symptom questionnaire
时间窗: After applying the Smart Homespital system(12weaks)
For survey scores, success is defined as an increase in the respective defined MCID(the minimal clinically important difference) rises the baseline. 1\) Chronic respiratory questionnaire (CRQ) * Success: 4 points or more 2.)Modified Medical Research Council dyspnea scale (mMRC) * Success: 1points or more 3) EQ-5D * Success: 1 points or more
次要结局
- Service satisfaction evaluation(After 12 weeks of applying the Smart Homespital system.)
- 6 minute walking test(At 3, 6, and 9 months.)
- Depression Questionnaire(Survey every 2 weeks during the 12-week Homespital system application, then at 3, 6, and 9 months after the start of the study.)
- safety(Measured after the study ends (9 months later).)
- cost assessment(After study ends (9 months later))
- pulmonary function test(At 3, 6, and 9 months.)
- system compliance(During the 12-week period of applying the Homespital system.)